Expert Guidance for Your Radiopharmaceutical Clinical Development Programs
Radiopharmaceutical drug development occupies a unique space in the pharmaceutical industry, with specific regulatory requirements and scientific hurdles to overcome. We leverage decades of experience to provide up to date and strategic direction in support of your clinical development plans.
Focused Clinical Expertise
Informed clinical trial design, sound FDA strategy and consistent execution will help ensure the success of your radiopharmaceutical development programs and ultimately deliver value to patients.
Nucleus taps into our deep experience in nuclear medicine and theranostic development which began at academia and evolved with work at FDA and numerous radiopharmaceutical companies. Our subject matter knowledge and extensive network allows us to guide clients in pursuing efficient paths to marketing authorization and clinical adoption.
Strategic Consulting Services
We can support your clinical development and medical affairs programs from early phase studies through FDA approval and product launch.
Consulting
Clinical development guidance and support for phase 1, 2, 3 and post marketing studies. Development and review of clinical protocols and related documents, FDA meeting guidance and attendance, study data interpretation and navigating complex regulatory scenarios.
Medical Affairs Support
KOL development, medical messaging strategy, product launch planning, presentation and conference attendance support.
Nucleus has a deep network of affiliate consultants with experience in radiopharmaceutical CMC, supply chains, theranostic clinical development, and medical affairs along with operators on the marketing and commercial side.
Drop us a line to see how we can support your development plans.
Phillip B. Davis, MD
Principal
Dr. Davis began his medical career at the Medical University of South Carolina (Charleston), where he earned his MD and completed an Internal Medicine internship and Nuclear Medicine residency. Joining the FDA in 2018, he spent 10 years in the Division of Imaging & Radiation Medicine (DIRM) where he managed numerous INDs and NDAs across multiple disease states and gained in depth knowledge of the Agency’s approach to radiopharmaceutical drug development. Dr. Davis also served as a consultant to other offices and centers as a radiopharmaceutical expert. Since 2019, Phillip has helped multiple companies, large and small, usher novel radiopharmaceutical drugs into clinical use and FDA approval. He lives in Charleston with his wife and their 3 children, where he enjoys spending time outside and on the waterways of SC.
Drop Us a Line
Interested in learning more about how Nucleus can support your clinical development or medical affairs activities?
Drop us a note and let’s start the conversation.